Introduction and objective
This study aims to evaluate safety and efficacy of different endoscopic enucleation of the prostate (EEP) techniques, by comparing laser (L-EEP) and non-laser (NL-EEP) procedures; and EEP versus other endoscopic non-enucleation (ENE) surgeries for benign prostatic enlargement (BPE).
A systematic literature review was performed for randomized clinical trials (RCT) that compared different endoscopic treatments for BPE, between 1982 and 2018. Two analyses were performed: (1) EEP versus ENE; and (2) L-EEP versus NL-EEP. Efficacy was assessed using perioperative data (removed tissue volume, operation time (OT), catheterization time, length of hospital stay); and functional outcomes [IPSS, IIEF-5, maximum flow rate (Qmax), postvoid residual volume (PVR), quality of life (QoL)]. Safety was assessed through complications (Hb and sodium decrease, transfusion rate). Meta-analyses were performed using RevMan® 5.3.
Out of 35 RCTs (4066 patients), 31 (3909 patients) evaluated EEP versus ENE, and 4 (327 patients) evaluated L-EEP versus NL-EEP. EEP presented greater Qmax. Also, EEP presented less catheterization time, length of hospital stay, Hb decrease, transfusion rate. OT and bladder injury were greater with EEP. There were no significant differences between other items. L-EEP removed more tissue volume, with a smaller drop in serum Hb. There were no significant differences in other perioperative data, functional outcomes, complications.
EEP and ENE are effective and safe for treating BPE. Perioperative data favors EEP. Statistical differences, with questionable clinical significance in functional outcomes and complication rates were encountered. L-EEP provides greater tissue removal and smaller Hb decrease then NL-EEP, with similar functional profiles.
Benign prostatic enlargement (BPE) is the most common benign neoplasm in men and affects more than 50% of men over 60 years old . Almost 30% of patients with lower urinary tract symptoms (LUTS) due to BPE need treatment, and about 20% are refractory to clinical treatment and therefore undergo surgery. Several surgical techniques are available to treat BPE . Recent technological developments aim to maintain excellent functional outcomes while reducing the morbidity associated with the procedure.
Endoscopic enucleation of the prostate (EEP)  is a minimally invasive procedure that can be used on prostates of any volume and can be performed through different energy sources . EEP supposedly provides excellent durable functional results and lower comorbidity rates. Nevertheless, it is still underperformed worldwide . The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of EEP options versus other endoscopic procedures that do not enucleate the prostate (ENE). Furthermore, in the EEP group, techniques that use laser as the energy source (L-EEP) were compared to techniques that do not use lasers (NL-EEP).
Literature search and inclusion of studies
This study was conducted following the PRISMA criteria and registered on and approved by PROSPERO (CRD42018099714). A systematic review was conducted to identify randomized clinical trials (RCTs) published in English from 1982 to December 2018 on the Pubmed, Embase, and Cochrane databases. Two authors participated in the literature search (SBT and PPK), and three participated in the data acquisition process (SBT, PPK, and BSA). The following keywords were used in the databases: MEP OR MTUEP OR MTUERP OR BEP OR BTUEP OR BTUERP OR TUEB OR THULEP OR TUERP OR TUEP OR HOLEP OR GREENLEP OR GLEP OR PKEP OR DILEP OR ELEP OR MONOPOLAR OR BIPOLAR OR THULIUM OR HOLMIUM OR GREENLIGHT OR PLASMAKINETIC OR PLASMA KINETIC OR DIODE OR ERASER AND ENUCLEATION AND PROSTATE OR SIMPLE PROSTATECTOMY.
After the exclusion of duplicate studies and congress abstracts, the first selection was done based on papers’ titles and abstracts (SBT and PPK). Articles were included if they compared endoscopic treatment techniques that reported perioperative data, functional outcomes, or complication rates. Once selected, the full text of the articles was studied to gather information about the study design and inclusion criteria. The evaluation of treatment efficacy included perioperative parameters (surgical time, removed tissue weight, catheterization time, length of hospital stay) and functional outcomes (international prostate symptom score [IPSS], international index of erectile function [IIEF], maximum flow rate [Qmax], quality of life [QoL], and post voiding residual volume [PVR]). These findings were divided into the following postoperative periods: immediate (1 month), short term (3–6 months), medium term (12–18 months), and long term (≥ 24 months). Treatment safety was evaluated according to the decrease in hemoglobin (Hb) and sodium (Na), hemotransfusion rate, bladder injury, acute urinary retention, re-catheterization, urinary tract infection, transient incontinence, urethral stenosis, re-operation rates, and transurethral resection syndrome (TURS) divided into immediate (1 month), short term (until 12 months) and long term (> 12 months).
The methodological quality of the RCTs was analyzed using the Jadad composite scale . Two reviewers (JDC and MLW) independently allocated quality scores to the identified studies. Disagreements were resolved by consensus.
To compare enucleation to non-enucleation endoscopic surgeries, the surgical techniques were grouped according to the main procedure that was performed. Therefore, the group of ENE procedures included monopolar and bipolar transurethral resection of the prostate (M and BTURP), plasmakinetic resection of the prostate (PKRP), transurethral vaporization in saline (TUVis), and photovaporization of the prostate (PVP). The EEP group included holmium laser enucleation of the prostate (HoLEP), thulium laser enucleation of the prostate (ThuLEP), diode laser enucleation of the prostate (DiLEP), eraser laser enucleation of the prostate (ELEP), plasmakinetic enucleation of the prostate (PKEP), plasma kinetic enucleo-resection of the prostate (PKERP) photovaporization and enucleation of the prostate (PVEP), bipolar transurethral enucleation of the prostate (BTUEP) and monopolar transurethral enucleo-resection of the prostate (MTUERP). The L-EEP group consisted of HoLEP, ThuLEP, DiLEP, and ELEP, while the NL-EEP group included PKEP, PKERP, BTUEP, and MTUERP techniques.
Data were independently extracted from each report by three authors (SBT, PPK, and BSA) using a data record developed for this purpose. After extraction, the data were reviewed by the first author. Instances of disagreement between the extractors were resolved by reaching consensus among researchers.
A meta-analysis was considered for each outcome including perioperative data, efficacy, or complications for every head-to-head comparison. The meta-analysis was conducted using RevMan® software v.5.3 (Cochrane Collaboration, Oxford, UK). Statistical heterogeneity was tested using the I2 test. The results were expressed as the weighted mean difference with the 95% confidence interval (CI) for continuous outcomes and as the odds ratio (OR) with a 95% CI for dichotomous variables. A meta-analysis of continuous variables was possible only for studies reporting them as means and standard deviations.
Characteristics of eligible studies
The initial database search yielded 359 records. After the removal of duplicates, 239 articles were considered. Articles were excluded if they were duplicates (n = 23), clinical trials registry (n = 13), editorials or comments (n = 6), meeting abstracts (n = 72), non-randomized studies (n = 19), articles in other languages (n = 5), irrelevant topics (n = 31), reviews (n = 9), and articles updated in more recent publications (n = 6). A total of 59 articles were considered for full text review. Two articles were eliminated because they were not RCTs, nine were updated in recent publications, and 13 did not compare endoscopic techniques. Figure 1 shows the flow diagram. Thirty-five studies were selected for the meta-analysis. Among the enrolled studies, 31 papers (3909 patients) compared endoscopic techniques to treat BPE (EEP vs. ENE), and 4 articles (327 patients) compared L-EEP and NL-EEP. Table 1 shows the studies’ characteristics and patients’ baseline parameters.
Outcomes of efficacy variables in EEP vs. ENE
IPSS data were obtained from 25 trials [7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31]. There were 18 trials that reported IPSS at 1 month [7, 8, 10,11,12,13, 15, 16, 19,20,21,22, 24,25,26,27, 30, 31], 21 trials reporting it at 3–6 months [7,8,9,10,11,12, 14,15,16, 18,19,20,21,22,23,24, 26, 27, 29,30,31], 16 trials reporting it at 12–18 months [7, 8, 10,11,12,13, 15, 16, 19,20,21, 24, 25, 27, 30, 31], and nine trials reporting it over 24 months [7, 10, 16, 17, 20, 27, 28, 30, 31]. EEP presented a better IPSS than non-enucleation techniques in the postoperative period of 12–18 months (− 0.86, 95% CI [− 1.44, − 0.29], p < 0.05, I2 = 92%). However, there were no significant differences in IPSS during 1 month, 3–6 months, and > 24 months post-operation (Fig. 2).
Qmax data were acquired from 25 trials [7, 9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28, 30,31,32,33]. Seventeen studies reported Qmax at the first postoperative month [7, 10,11,12,13, 15, 16, 19,20,21,22, 24,25,26,27, 30, 31], 21 reported it at 3–6 months [7, 9,10,11,12, 14,15,16, 18,19,20,21,22,23,24, 26, 27, 30,31,32,33], 17 reported it at 12–18 months [7, 10,11,12,13, 15, 16, 18,19,20,21, 24, 25, 27, 28, 30, 31], and 10 reported it over 24 months [7, 10, 16, 17, 20, 21, 27, 28, 30, 31]. There was a significant benefit of EEP in terms of Qmax in the immediate (1.06 ml/s, 95% CI [0.26, 1.87], p < 0.05, I2 = 87%), short-term (1.00 ml/s, 95% CI [0.3, 1.7], p < 0.05, I2 = 81%), and long-term (1.77 ml/s, 95% CI [1.71, 1.84], p < 0.05, I2 = 68%) follow-up periods (Fig. 3).
IIEF scores comparing EEP and non-enucleation techniques were obtained from six trials [10, 17, 20, 30, 31, 33]. There were no significant differences according to a pooled analysis of IIEF scores at 1 month, 3–6 months, 12–18 months, and 2 years or more post-operation (Fig. 4).
PVR data were obtained from 16 trials [7, 8, 10,11,12, 14, 15, 19, 20, 22, 23, 25,26,27,28, 30]. Ten trials reported PVR at 1 month [7, 8, 11, 12, 15, 19, 20, 22, 26, 30], 15 reported it at 3–6 months [7,8,9,10,11,12, 14, 15, 19, 20, 22, 23, 26, 27, 30], eight reported it at 12–18 months [7, 11, 12, 15, 19, 20, 25, 30], and four reported it at 2 years or more [7, 20, 28, 30]. EEP had a lower PVR than ENE techniques during the short- and medium-term follow-up periods (− 6.00 ml, 95% CI [− 8.30, − 3.69], p < 0.05, I2 = 87%; − 9.57 ml, 95% CI [− 14.98, − 4.15], p < 0.05, I2 = 93%). However, there were no significant differences in PVR in either the immediate-term or in the long-term follow-up periods (Fig. 5).
QoL data were obtained from 15 trials [8, 10, 11, 15,16,17, 21, 22, 24,25,26,27,28,29,30]. Twelve trials reported QoL at 1 month [8, 10, 11, 15, 16, 21, 22, 24,25,26,27, 30], 12 reported it at 3–6 months [8, 10, 11, 15, 16, 21, 22, 24, 26, 27, 29, 30], 11 reported it at 12–18 months [8, 10, 11, 15, 16, 21, 24, 25, 27, 28, 30], and seven reported it over 24 months [10, 16, 17, 21, 27, 28, 30]. The pooled analysis showed no significant differences in QoL between EEP and ENE techniques at each follow-up time point (Fig. 6).
Perioperative data in EEP vs. ENE (Fig. 7)
EEP was associated with longer operative time (12.46 min, 95% CI [5.80, 19.11], p < 0.05, I2 = 96%) in pooled data from 26 studies (3097 patients) [7,8,9,10,11,12,13,14,15,16, 18,19,20,21,22,23,24,25,26, 28,29,30, 34,35,36,37,38].
Resected prostate weight
There were 21 trials [8,9,10, 12, 14, 16, 18,19,20,21,22,23,24,25,26, 30, 31, 34,35,36, 38, 39] that reported resected prostate weight (2422 patients). The pooled results showed no statistically significant difference between groups (4.66 g, 95% CI [− 1.75, 11.07], p = 0.15, I2 = 98%).
EEP was associated with a shorter catheterization time (− 0.58 days, 95% CI [− 0.89, − 0.28], p < 0.05, I2 = 98%) in pooled data from 25 studies (2896 patients) [7,8,9,10,11,12, 15, 16, 18,19,20,21,22,23,24,25,26, 28,29,30,31, 34, 36,37,38,39].
Length of hospital stay
EEP was associated with shorter length of hospital stay (− 0.91 days, 95% CI [− 1.22, − 0.60], p < 0.005, I2 = 96%) in pooled data from 20 studies (2599 patients) [8,9,10,11,12, 15, 16, 19,20,21,22, 24,25,26, 28,29,30, 34, 35, 38, 39].
Complications in EEP vs. ENE (Fig. 8)
We extracted data on the decrease of serum Hb from 21 studies (2441 patients) [7,8,9,10, 12, 15, 18,19,20, 22, 24, 26, 28,29,30,31, 34,35,36,37,38,39]. EEP was associated with a smaller drop in serum hemoglobin levels than ENE (− 0.54 mg/dl, 95% CI [− 0.87, − 0.20], p < 0.005, I2 = 98%).
There were no statistical differences between EEP and ENE with respect to Na decrease after analyzing 11 studies (1389 patients) [7, 10, 18, 20, 29, 30, 34,35,36,37,38,39] (− 0.35 mEq/L, 95% CI [− 0.76, 0.07], p = 0.1, I2 = 91%).
EEP was associated with a lower hemotransfusion rate (OR 0.38, 95% CI [0.21, 0.67], p < 0.005, I2 = 0%) in a pooled data analysis of 19 studies (2288 patients) [7,8,9, 12, 15, 18, 20, 21, 23, 25,26,27, 29,30,31, 34,35,36,37, 39].
There were no statistical differences between EEP and ENE with respect to transient incontinence after an analysis of 13 studies (1450 patients) [7, 8, 11, 12, 19,20,21, 23, 24, 26, 29, 30, 34, 37] (OR 1.19, 95% CI [0.71, 2.00], p = 0.5, I2 = 31%).
We extracted data on bladder injury from 7 studies (817 patients) [7,8,9, 18, 24, 26, 34, 35], and the rate of bladder injury was significantly higher in the EEP group (OR 4.31, 95% CI [1.44, 12.92], p < 0.005, I2 = 0%).
There were no statistical differences between EEP and ENE with respect to urinary tract infection (OR 0.49, 95% CI [0.19, 1.28], p = 0.15) [7, 19, 21, 26, 30, 37], acute urinary retention (OR 0.51, 95% CI [0.15, 1.71], p = 0.27) [7, 8, 24, 26, 34, 35, 37], recatheterization need (OR 0.80, 95% CI [0.38, 1.67], p = 0.55) [7, 18, 20, 21, 23, 26, 27, 36, 37, 39], and TURS (OR 0.24, 95% CI [0.03, 2.20], p = 0.21) [7, 20, 21, 24, 26, 30, 35, 37, 39].
There were no statistical differences between EEP and ENE with respect to urethral stenosis (OR 0.54, 95% CI [0.25, 1.14], p = 0.1) [7, 8, 12, 18,19,20, 24,25,26, 34,35,36,37], urinary incontinence (OR 0.64, 95% CI [0.10, 4.08], p = 0.63) [8, 24], and reoperation (OR 1.06, 95% CI [0.05, 22.02], p = 0.97) [8, 26, 35, 37, 38].
There were no statistical differences between EEP and ENE with respect to urethral stenosis (OR 0.86, 95% CI [0.36, 2.08], p = 0.74) [7, 21, 27, 30], bladder neck contracture (OR 1.01, 95% CI [0.34, 3.02], p = 1) [7, 21, 30, 36], and reoperation (OR 0.37, 95% CI [0.08, 1.72], p = 0.2) [7, 27, 30, 36].
Outcomes of efficacy variables in L-EEP vs. NL-EEP
There were no statistical differences between L-EEP and NL-EEP regarding IPSS, Qmax, and PVR at 3–6 months [32, 40, 41]. There was insufficient data to analyze IPSS, Qmax, IIEF, PVR, and QoL during other postoperative periods.
Perioperative data in L-EEP vs. NL-EEP
Resected prostate weight
Four trials [32, 33, 40, 41] reported the resected prostate weight of 327 patients. The L-EEP group was associated with a greater resected weight than the NL-EEP group (1.83 g, 95% CI [0.23, 3.43], p < 0.05, I2 = 0%).
There were no statistical differences between L-EEP and NL-EEP with respect to catheterization time after analyzing four studies (327 patients) (− 0.40, 95% CI [− 0.83, 0.02], p = 0.06) [32, 33, 40, 41].
Length of hospital stay
The length of hospital stay showed no statistical differences between L-EEP and NL-EEP in pooled data from four studies (327 patients) (− 0.38 days, 95% CI [− 0.81, 0.05], p = 0.08, I2 = 80%) [32, 33, 40, 41].
Complications in L-EEP vs. NL-EEP
We extracted data on decreases in serum Hb levels from three studies (287 patients) [32, 33, 41]. L-EEP was associated with a smaller drop in serum hemoglobin level than NL-EEP (− 0.32 g/dL, 95% CI [− 0.53, − 0.12], p < 0.05, I2 = 58%).
There were no statistical differences between L-EEP and NL-EEP with respect to Na decrease (− 0.60 mEq/L, 95% CI [− 1.51, 0.31], p = 0.19) [32, 41], transfusion rate (OR 0.36, 95% CI [0.01, 8.88], p = 0.53) [32, 41], urinary infection (OR 0.70, 95% CI [0.11, 4.40], p = 0.7) [32, 40], recatheterization need (OR 1.01, 95% CI [0.35, 2.96], p = 0.98) [32, 33, 40], and transient urinary incontinence (OR 0.77, 95% CI [0.33, 1.82], p = 0.55) [32, 33, 41].
There were no statistical differences between L-EEP and NL-EEP with respect to urethral strictures (OR 1.39, 95% CI [0.26, 7.61], p = 0.7) [32, 33, 40, 41] and urinary incontinence (OR 0.47, 95% CI [0.04, 5.69], p = 0.56) [40, 41].
No studies evaluated long-term complications, including strictures, bladder neck contracture, and reoperation.
TURP has been considered the standard endoscopic surgery technique for BPH treatment in patients with small and medium-sized prostates. For men with greater gland volumes, open prostatectomy  has been the most appropriate option. However, TURP still carries the risk of hemorrhage requiring blood transfusion (2–4.8%) and TURS (0–1.1%) , and open prostatectomy is associated with elevated morbidity . Thus, other minimally invasive procedures with excellent functional outcomes and lower complication rates have been adopted more frequently in recent years. Among these new techniques, EEP seems to be the most promising approach since long-term one-arm observational studies demonstrate a lasting improvement in quality of life and functional parameters, as well as a favorable safety profile [16, 17].
A meta-analysis comparing open prostatectomy to HoLEP has already been published , which demonstrated that EEP provides equivalent functional results but lower complication rates. For this reason, papers comparing simple prostatectomy to EEP were not evaluated. Another robust meta-analysis compared different endoscopic procedures  and head-to-head comparisons of specific technologies, such as HoLEP vs. B-TURP , THuLEP vs. TURP  have also been published. However, EEP has never been studied as a group and compared to other ENE techniques, despite the technology used to perform the procedure. This grouped analysis is of uttermost importance since EEP is a technically more challenging procedure and many institutions are willing to start performing enucleation surgeries.
In the present meta-analysis, EEP presented significantly better Qmax and IPSS improvements than ENE. Nevertheless, these differences are clinically questionable since the Qmax improvement between groups was 1.0 ml/s in the short term and 1.77 ml/s in the long term. Furthermore, the IPSS was just 0.86 points lower in the EEP group and only in the mid-term follow-up analysis. There was no difference in other functional outcomes and QoL, regardless of the follow-up period that was analyzed.
When comparing perioperative data between EEP and ENE, both presented effective results. However, there was a significant difference favoring EEP in regard to the catheterization time and length of hospital stay, but with longer surgical time. EEP is associated with less bleeding and lower transfusion rate but higher incidence of bladder injury.
It is widely stated that EEP may be associated with a greater risk of transient-stress urinary incontinence. Moreover, since the whole adenoma is removed, one would expect that greater tissue weight would be resected in EEP [10, 12, 16, 19, 20, 24, 25, 30, 31, 35, 36, 38]. Nevertheless, this study did not find any differences in these aspects among groups. This must be due to the fact that NL-EEP patients might have contaminated the enucleation group. This hypothesis is reinforced by the fact that when comparing L-EEP to NL-EEP, the first group had a greater resected weight. No differences were found in the risk of urethral stenosis in both the short and long-term analyses comparing EEP and ENE.
It remains unclear what the best energy source is to perform the surgery among prostate endoscopic enucleators. We sought to analyze studies that compared L-EEP and NL-EEP. There was no statistically significant difference in terms of functional outcomes. However, L-EEP was associated with a greater weight of resected tissue, but with no clinical significance. Surgical time, catheterization time, and length of hospital stay were similar in both groups. L-EEP was also associated with a lower decrease in Hb, but no differences were encountered in other complications.
Our study included only trials with level 1 evidence. However, our findings must be interpreted within the context of some limitations. First, the follow-up time was different among studies: only four studies [16, 17, 28, 31] had more than 5 years of follow-up, and most studies had a maximum follow-up of up to 12 months [8, 9, 11,12,13,14,15, 18, 19, 22,23,24,25,26, 32,33,34,35, 37, 39,40,41]. Therefore, the long-term efficacy and safety (beyond 5 years) comparing EEP and ENE cannot be evaluated due to lack of data. Second, there was high heterogeneity in the majority of the analysis, which could be explained by the heterogeneous population (with different inclusion criteria and different energy technologies for BPE treatment) included in each studied trial. Other aspects that may be emphasized are the impossibility of comparison according to preoperative prostate weight and the possible use of anticoagulants or antiplatelet therapies.
This study showed that EEP and ENE are both effective and safe for treating BPE. The majority of perioperative data favor EEP (lower Hb decrease, transfusion rate, catheterization time and length of hospital stay, but higher operation time and bladder injury rate). Besides statistical differences in functional outcomes and complication rates, the clinical significance of these findings is questionable. Compared with NL-EEP, L-EEP provides greater tissue removal and a smaller Hb decrease with the same functional profiles.
Long-term RCTs may provide an answer about whether EEP could replace ENE as the gold standard treatment for BPE.
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Wroclawski, M.L., Teles, S.B., Amaral, B.S. et al. A systematic review and meta-analysis of the safety and efficacy of endoscopic enucleation and non-enucleation procedures for benign prostatic enlargement. World J Urol 38, 1663–1684 (2020). https://doi.org/10.1007/s00345-019-02968-4
- Endoscopic surgical procedures
- Outcomes assessments